Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005787
• Other study ID #: NU 99Z1
• Secondary ID: NU-99Z1NCI-G00-1
• Status: Terminated
• Phase: Phase 1
• First received: June 2, 2000
• Last updated: May 31, 2012
• Start date: September 1999
• Est. completion date: January 2002

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant.

PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.

Description:

OBJECTIVES:

• Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma.

• Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy.

• Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo.

• Determine the relationships between length of culture, immunophenotype, and clinical outcome.

• Determine the required numbers of white blood cell precursors for clinical efficacy.

• Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period.

OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.

Patients are followed monthly for 1 year.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2002
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 65 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven relapsed or refractory non-Hodgkin's lymphoma

• Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan) with autologous peripheral blood mononuclear cell transplantation

• No metastatic disease involving the bone marrow

PATIENT CHARACTERISTICS:

Age:

• 17 to 65

Performance status:

• ECOG 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• No active hepatitis B or C

• Bilirubin less than 2.5 times normal*

• SGOT or SGPT less than 2.5 times normal*

• Alkaline phosphatase less than 2.5 times normal NOTE: * Unless Gilbert's syndrome present

Renal:

• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• Cardiac ejection fraction normal

Pulmonary:

• DLCO at least 50% predicted

• FEV_1 and FVC at least 75% predicted

Other:

• HIV negative

• Not pregnant

• Negative pregnancy test

• No non-neoplastic disease that would preclude intensive chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior external beam radiotherapy to more than 25% of the active bone marrow

Surgery:

• Not specified

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lymphoma
• Neutropenia

Intervention

Biological:
• epoetin alfa

• filgrastim

• recombinant flt3 ligand

• recombinant interleukin-3

• sargramostim

Procedure:
• in vitro-treated peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,